Effects of Cannabis Abstinence on Symptoms and Cognition in Depression
Raktažodžiai
Santrauka
Datos
| Paskutinį kartą patikrinta: | 01/31/2019 |
| Pirmasis pateikimas: | 07/24/2018 |
| Numatytas registravimas pateiktas: | 08/06/2018 |
| Pirmas paskelbtas: | 08/09/2018 |
| Paskutinis atnaujinimas pateiktas: | 02/27/2019 |
| Paskutinis atnaujinimas paskelbtas: | 03/03/2019 |
| Faktinė studijų pradžios data: | 11/05/2017 |
| Numatoma pirminio užbaigimo data: | 11/30/2019 |
| Numatoma studijų užbaigimo data: | 11/30/2019 |
Būklė ar liga
Intervencija / gydymas
Behavioral: 28-Day Cannabis Abstinence
Behavioral: 28-Day Cannabis Abstinence
Fazė
Rankų grupės
| Ranka | Intervencija / gydymas |
|---|---|
| Experimental: 28-Day Cannabis Abstinence The study will assess the changes that occur after a 28-day abstinence period in patients with Major Depressive Disorder (MDD) and comorbid Cannabis Use Disorder (CUD). Patients will be instructed to initiate abstinence 12 hours prior to the baseline session and will come in for weekly visits involving a series of clinical, cognitive, and substance use assessments. | Behavioral: 28-Day Cannabis Abstinence The participants will be provided with a 20-minute individual behavioral support session weekly for 4 weeks (28 days of abstinence), designed to provide them with tools and techniques to manage the craving and withdrawal symptoms that occur with cessation. |
Tinkamumo kriterijai
| Amžius, tinkami studijuoti | 18 Years Į 18 Years |
| Tinkamos studijoms lytys | All |
| Priima sveikus savanorius | Taip |
| Kriterijai | Inclusion Criteria: - ages 18-55 - meet DSM-5 diagnostic criteria for cannabis use disorder (cannabis use >1 g/day, CUDIT score >12) - meet DSM-5 diagnostic criteria for Major Depressive Disorder as determined using the SCID - be an outpatient receiving a stable dose of antidepressant medication(s) for at least 1 month - have a Hamilton Depression Rating Scale (HDRS-17) baseline total score greater than 14 - have a Full Scale IQ greater than 80 as determined by the WTAR - be a non-treatment seeking cannabis user - evidence of sufficient motivation and effort as measure by a Test of Memory Malingering (TOMM) score greater than 45 - urinary baseline THC-COOH levels greater than 150 ng/ml Exclusion Criteria: - meets criteria for abuse or dependence of alcohol or other illicit substances within the part 6 months (with the exception of cannabis, nicotine, or caffeine) - positive urine screen for illicit substances other than cannabis, nicotine or caffeine - current suicidal or homicidal ideation - psychotic disorder diagnosis (e.g. schizoaffective disorder, major depression with psychotic features) as determined by the SCID - head injury with loss of consciousness greater than 2 minutes or requiring hospitalization - neurological or medical condition determined to effect cognition - be treatment seeking for cannabis use |
Rezultatas
Pirminės rezultatų priemonės
1. The effects of 28 day cannabis abstinence on change in depressive symptoms in cannabis-dependent patients with Major Depressive Disorder (MDD) as assessed by the Hamilton Rating Scale for Depression (HRSD). [Weekly (Day 0, Day 7, Day 14, Day 21, Day 28) and at 8 weeks (Follow-up Day 56)]
Antrinės rezultatų priemonės
1. The effects of 28 day cannabis abstinence on change in cognitive function in cannabis dependent patients with Major Depressive Disorder (MDD) as assessed by a cognitive battery administered at Baseline, Week 2, Endpoint and Follow-Up. [Bi-Weekly (Day 0, Day 14, Day 28) and at 8 Weeks (Follow-up Day 56)]
2. The effects of 28 day cannabis abstinence on change in co-occurring anxiety in cannabis dependent patients with MDD as assessed by the Beck Anxiety Inventory (BAI) administered weekly. [Weekly (Day 0, Day 7, Day 14, Day 21, Day 28) and at 8 weeks (Follow-up Day 56)]
